FDA Denies Approval of Ampligen

The FDA has informed Hemispherx Biopharma Inc. that research on its experimental drug Ampligen is insufficient to support the drug’s approval for treatment of chronic fatigue syndrome (ME/CFS). The FDA has indicated that at least one more study would be required to credibly demonstrate the drug’s efficacy and safety for treatment of ME/CFS, according to a report featured December 1 by CNNMoney.com and news alerts issued by a number of other pharmaceutical & financial market trackers.

According to the reports, the FDA stipulated a number of requirements that further trials should satisfy, including size, duration, and monitoring criteria. Philadelphia-based Hemispherx has indicated it intends to make a prompt response to the FDA’s suggestions “its top priority.”